MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965040S

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Locking screw said to be of incorrect length out of box.On x-ray, the implant appeared shorter than required.

Manufacturer Narrative

The evaluation revealed the locking screw to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The screw was documented as faultless prior to distribution.An investigation was not possible because the locking screw was not provided; the root cause could not be determined.The customer reported that the screw length was recognized via x-ray.X-rays are not adequate for dimension measurements; maybe the chosen screw was too short/long for the bone.Therefore the correct screw length has to be checked prior every locking screw insertion using a screw gauge or the drill scale.Because the dhr review shows no deviations a manufacturer related issue can be excluded.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

Locking screw said to be of incorrect length out of box.On x-ray, the implant appeared shorter than required.

Manufacturer Narrative

The evaluation revealed the locking screw to be the primary product.Deviations in the manufacturing documents were not found.Length measuring revealed the screw being within specifications.The returned screw was in accordance to the specification.As early as in (b)(6) 2003 a change request had been implemented in order to decrease soft tissue irritation.Therefore the height of the screw head had been reduced from 4mm to 3.1mm.The nominal length of the locking screw, fully threaded, ø5x40 mm, is 39 (-0,5) mm measured from the tip including the screw head.The effective thread length was not affected by this change.Thus, the length of the returned locking screw is within specified parameters.Found damages on the thread of the screw confirmed that it was implanted and placed in a nail hole.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

Locking screw said to be of incorrect length out of box.On x-ray, the implant appeared shorter than required.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6093946
• MDR Text Key: 60025733
• Report Number: 0009610622-2016-00502
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 18965040S
• Device Lot Number: K0CC8CF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2017; 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other